Senior Engineer, Design Assurance QA R&D

About HOYA Surgical Optics (HSO)

HOYA Surgical Optics (HSO) is the globally leading Preloaded Intraocular Lens (IOL) focused company that provides technologies and solutions that exceed expectations, enabling ophthalmic surgeons to focus on restoring sight. We are dedicated to improving the vision and quality of life for millions of people suffering from cataract, and helping them celebrate life visually.

HSO empowers cataract surgeons all over the world with innovative ophthalmic devices and services, with an attention to detail that helps them achieve better surgical outcomes and better practice results. Our commitment to delivering these results is grounded upon a quality management system that is continuously improving to meet changing global regulatory requirements and our entrepreneurial drive to be the brand of first choice.

At HSO, People is the key factor to our success. We aim to create a conducive work environment for our employees around the globe, and to promote an inclusive culture based on our core values – Excellence, Passion, Innovative, Collaboration, and Accountability.

HSO way of working

In fulfilling our roles, we are

• Accountable for our own capabilities and development.
• Focused on delivering results without excuses, and
• Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively.

We are looking for people who

• See beyond self and are impact focused.
• Consider the needs, challenges, and objectives of every person they interact with
• Exhibit positive reinforcement to help others succeed.

Job Description

About the role

Works closely with and have impact on: Global R&D team, Post market surveillance and Regulatory Affairs

Reports to: Senior Manager QA R&D HSOU, Global QA & Compliance

Role Overview

The primary function of this position is to manage the Design Assurance activities for assigned projects in QA R&D Portfolio. This position collaborates with global cross functional team to achieve quarterly, midterm, and annual objectives and works under minimal supervision.

The Senior Engineer, Design Assurance QA R&D is also responsible for ensuring that products meet quality goals and regulatory requirements, including but not limited to FDA Regulations, ISO 13485, EU MDR requirements, MDSAP requirements, Usability Engineering per IEC-62366-1 and Risk Management per ISO 14971.

Duties and Responsibilities

• Partner with R&D teams in the USA, Japan, and Singapore to ensure that design control is completed in accordance with procedures, Work Instructions (WI), regulatory requirements, and assure that required outputs have been completed
• Manage all design assurance and usability engineering activities for R&D projects
• Ensure Design History Files (DHF) and all project design documentation are properly maintained in the Documentation Control System (i.e., Master Control).
• Ensure all design control deliverables, drawings are approved at the respective design gates
• Review design review materials to ensure consistency in the format and information reflected in the respective design gate
• Act as a core team lead for design control projects to review design verification protocols and reports, verify the requirement and criteria set are consistent in all design control deliverables, and advise on the approvers to be included for the documents.
• Assist in the development and approval of design development plans, verification and validation protocols, reports, master V&V plans and reports, and design transfer
• Review documents for labelling
• Review documents for biocompatibility studies per ISO 10993-1 biological evaluation of medical devices
• Review and approve R&D documents (e.g., IQ , OQ, PQ, WI, etc.) within areas of responsibility
• Review design transfer documents and coordinate transfer to both manufacturing and Regulatory Global Technical Dossier
• Process improvements initiatives within Design Assurance and Usability Engineering in line with regulations, standards and internal policies and procedures
• Maintain and improve global operating procedures and work instructions
• Support lifecycle management of marketed products
• Conduct design assurance training to global R&D teams and other functions as needed
• Support internal or external audits as needed with respect to R&D projects and related documentation
• Create corrective action plans for findings from internal and external audits concerning design control procedures and deliverables
• Manage design change control for design control projects in accordance with SOP
• Thoroughly review R&D technical reports to ensure quality and minimize deficiencies
• Support and foster a performance driven/oriented culture

Requirements

Experience

• At least 10 years of experience in medical devices
• At least 6 years of working experience as Design Assurance and/or Design QA or QA R&D Engineer in Medical Device/ Pharmaceutical product or optical engineering business field.
• Experience with New Product Development (NPD) projects
• Experience in test method validation.
• Demonstrated knowledge of Design Assurance requirements per FDA Regulations, ISO 13485, EU MDR requirements, MDSAP requirements, Risk Management per ISO 14971, Usability Engineering per IEC-62366-1, Testing and Calibration per ISO 17025 and Biocompatibility studies per ISO 10993

Skills/Accreditations

• Analytical mind capable of analyzing a broad spectrum of engineering and life science areas
• Having a proven drive for results, is highly tenacious and persistent in the face of obstacles to ensure strategies are implemented over long term effectively
• Demonstrated experience working and leading in a matrix organization and in global teams (i.e., relationships with other departments, understanding of cross-functional priorities)
• Excellent written, verbal and presentation skills in English required as this is a global role.
• Strong intercultural experience
• Ability to work collaboratively with scientist, engineers and other leaders
• Strong project management skills
• Strong interpersonal, communication skills, and problem-solving skills
• Understanding of the medical device business, preferred in ophthalmology
• Working knowledge of US, EU and JP standards for medical devices is desired
• Excellent leadership skills & role model of HOYA Surgical Optics core values (i.e. Excellence, Passion, Innovative, Collaborative, Accountability)
• Ability to drive and execute responsibilities under minimal supervision

Academic Qualifications

• BS degree in Engineering or Life Sciences with 10 years of relevant experience; MS preferred
• Auditor or Lead Auditor Certification for ISO 13485 and/or MDSAP preferred
• ASQ Certification (CQE or CQA) preferred
• Six Sigma Green Belt certification preferred

Travel requirements

• Up to 20%
• USA domestic travel, and 1-2 international travel mainly Japan, Thailand or Singapore.